Cervical Plate System
FDA 510(k) K201979 · Eminent Spine, LLC
510(k) numberK201979
Submission
- Device name
- Cervical Plate System
- Applicant
- Eminent Spine, LLC
Plano, TX, US - Received
- July 16, 2020
- Decision date
- August 25, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261309 | Palisades Buttress Plate SystemKWQ · Traditional | Bethesda Medical Devices, LLC | 07/16/2026SE |
| K252776 | ARIES Anterior Cervical Plate SystemsKWQ · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/14/2026SE |
| K261112 | CastleLoc-P Anterior Cervical Plate SystemKWQ · Special | L&K BIOMED Co., Ltd. | 05/06/2026SE |
| K260570 | corra cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 04/22/2026SE |
| K260697 | VyPlate Anterior Cervical Plate SystemKWQ · Special | Vy Spine, LLC | 03/27/2026SE |
| K260015 | ANTERIS Thoracolumbar Plate SystemKWQ · Traditional | SpineCraft | 03/04/2026SE |
| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 03/03/2026SE |
| K254182 | AsterKWQ · Traditional | Osteonic Co., Ltd. | 02/26/2026SE |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special | 4Web, Inc. | 02/12/2026SE |
| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
More from Carlsmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250894 | Eminent Spine Posterior SI SystemOUR · Traditional | 10/07/2025SE |
| K241663 | Eminent Spine 3D Titanium Pedicle Screw SystemNKB · Traditional | 04/28/2025SE |
| K242069 | Eminent Spine Scoliosis Deformity Pedicle Screw SystemNKB · Special | 09/03/2024SE |
| K240505 | Eminent Spine SI Screw SystemOUR · Traditional | 06/04/2024SE |
| K230219 | Eminent Spine 3D Lumbar Interbody Fusion SystemsMAX · Traditional | 05/16/2023SE |
| K212701 | Eminent Spine 3D Cervical Interbody Fusion SystemODP · Traditional | 02/06/2023SE |
| K221936 | Standalone ALIF Interbody Fusion SystemOVD · Traditional | 10/17/2022SE |
| K212853 | Cervical Stand-Alone SystemOVE · Traditional | 11/05/2021SE |
| K143365 | Eminent Foot Plate SystemHRS · Traditional | 03/30/2015SE |
| K133194 | Diamond Rattlesnake SystemKWQ · Traditional | 06/26/2014SE |
Questions and answers
When was Cervical Plate System cleared by the FDA?
Cervical Plate System (K201979) received a 510(k) decision of Substantially Equivalent on August 25, 2020, 40 days after the submission was received.
What is the product code of K201979?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.